Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:

Time to local, regional, and/or distant failure [ Time Frame: Up to 5 years after dose of last treatment ]

Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.

Secondary Outcome Measures:

Number and grade of adverse events experienced by patients [ Time Frame: Up to 5 years after last dose of treatment ]

Adverse events will be monitored weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.

Number of patients requiring a surgical revision of their reconstruction [ Time Frame: Up to 5 years after dose of last treatment ]

Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Radiation: External beam radiation therapy

Hypofractionated accelerated radiation therapy over 11 days

Other Name: EBRT

Detailed Description:

PRIMARY OBJECTIVES:

I. Freedom from local failure and freedom from regional failure.

SECONDARY OBJECTIVES:

I. Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy.

III. To correlate toxicity, cosmesis, and local control with molecular markers.

OUTLINE:

Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.

Tamoxifen, Arimidex or other hormonal therapy is allowed; it may begin any time relative to the radiation at the discretion of the treating physician

Chemotherapy is allowed, if chemotherapy is indicated the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy; neoadjuvant chemotherapy is allowed; radiation therapy will be delivered after mastectomy or after any adjuvant chemotherapy as described above

Chest wall reconstruction is allowed

The patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy

Patients with co-existing medical conditions with life expectancy < 2 years

Patients with psychiatric (with the possible exception of incompetence as defined by New Jersey [NJ] law) or addictive disorders that would preclude obtaining informed consent

Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous

Women who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females

Women who are able to conceive and unwilling to practice an effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417286